SeaStar Medical announces FDA granted HDE approval order to SCD-PED

SeaStar Medical Holding announces that the U.S. Food and Drug Administration, FDA, has granted a Humanitarian Device Exemption, HDE, Approval Order to the Selective Cytopheretic Device, SCD, Pediatric, SCD-PED, for use in children weighing 10 kilograms or more with acute kidney injury (AKI) due to sepsis or a septic condition requiring kidney replacement therapy. This is the first product in the Company’s newly branded Quelimmune product family, and the Quelimmune pediatric device can now be commercially marketed as a Humanitarian Use Device. “This first regulatory approval is a major accomplishment for our company and, most importantly, it provides critically ill children with AKI access to a much-needed new therapy,” said Eric Schlorff, SeaStar Medical CEO. “Only about one-half of the children in the ICU with AKI requiring CKRT survive, and those who do are at increased risk of long-term conditions such as chronic kidney disease. In clinical studies, Quelimmune for pediatric AKI has been shown to reduce mortality rates and dialysis dependency in clinical studies.